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expiration time limit of recruitment
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Aim: To demonstrate the non-inferiority of the PRO-067 ophthalmic solution manufactured by Laboratorios Sophia S.A. de C.V. versus GAAP Ofteno® ophthalmic solution like hypotensive therapy in subjects with primary open angle glaucoma or ocular hypertension.
Study design: a multicentric, prospective, crossover (2x2), double blind clinical study. Sample size: one hundred patients with primary open angle glaucoma or ocular hypertension. Patients in the period 1: In the first sequence 60 patients will be assigned to receive the ophthalmic solution: GAAP Ofteno ® (latanoprost 0.005%) 1 drop per day (QD) during 30 days and the second sequence 60 patients will be assigned to receive the ophthalmic solution: PRO-067 1 drop QD during 30 days in the same period. Washout period: 21 hours. Patients in the period 2: the pharmacological intervention change to the opposite therapy for 30 days.
The American Academy of Ophthalmology Glaucoma Panel The primary open angle glaucoma (POAG) is a progressive, chronic optic neuropathy in adults in which intraocular pressure (IOP) and other currently unknown factors contribute to damage and in which, in the absence of other identifiable causes, there is a characteristic acquired atrophy of the optic nerve and loss of retinal ganglion cells and their axons. This condition is associated with an anterior chamber angle that is open by gonioscopic appearance.
This is a multicentric, crossover, double blind and prospective clinical study. The investigators will include patients with confirmed diagnosis of primary open-angle glaucoma or ocular hypertension, with target intraocular pressure (TIOP) within a range at which a patient is likely to remain stable or at which worsening of glaucoma will be slow enough that the risk of additional intervention is not justified.
Patients will be randomly divided into 2 groups, one of them treated with a known formulation of Latanoprost 0.005% (GAAP Ofteno®, Laboratorios Sophia, Mexico) and the other one treated with PRO-067 ophthalmic solution. Patients will receive 1 drop per day (QD) into the lower conjunctival sac of either formulations and were examined at days: 1, 15, 30, 45 ad 60 after initiation of treatment. A phone call security at day 75 will be performed.
Primary efficacy outcome: To evaluate the efficacy of PRO-067 versus GAAP Ofteno ® instilled onto the ocular surface in subjects with primary open angle glaucoma (POAG) or ocular hypertension (HTO), to control and maintenance of the target intraocular pressure (TIOP).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 (PRO-067) | Experimental | study subjects will be allocated to receive PRO-067 QD for 30 days, after which they will be crossed over to the other medication (GAAP Ofteno®) for another 30 days. The Intraocular pressure-reducing effect of the medications will be assessed by the reduction in IOP after each medication compared to baseline. Washout period: 21 hours |
|
| Sequence 2 (GAAP Ofteno®) | Active Comparator | study subjects will be allocated to receive GAAP Ofteno® QD for 30 days, after which they will be crossed over to the other medication (PRO-067) for another 30 days. The Intraocular pressure-reducing effect of the medications will be assessed by the reduction in IOP after each medication compared to baseline. Washout period: 21 hours |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRO-067 | Drug | 1 drop QD during 30 days is a sterile ophthalmic solution formulated by Laboratorios Sophia S.A. de C.V. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Target Intraocular Pressure (TIOP) | Target Intraocular Pressure (TIOP): Efficacy of experimental drug or active comparator to maintain the IOP in a range at which a patient is likely to remain stable or at which worsening of glaucoma will be slow enough that the risk of additional intervention is not justified.The upper limit of intraocular pressure is: TIOP + 2 mmHg. The measurement of the TIOP in each treatment period. | the baseline visit (day 0), Cross Over Visit (day 30) and the final visit (day 60) for both sequences |
| Number of Adverse Events. | the two periods of PRO-067 of each sequence were grouped as well as those of GAAP to form two comparative groups of adverse events in each intervention. (PRO-067 vs. GAAP ofteno). The number of adverse events presented throughout the study was evaluated with each study drug to make the comparison between groups. | it is evaluated from the baseline visit (day 1) to the security call (day 75) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Ocular Burning | the ocular burning of the study subjects was evaluated, during the baseline, crossover and final visit, the variable was described as present or absent, according to the case, in both groups. A Pearson´s chi-square test is performed in the crossover and final visit to compare the end of periods 1 and 2 between both study sequences. | at the basal visit (day 1) crossover visit (day 30) and final visit (day 60) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leopoldo Baiza Durán, MD | Laboratorios Sophia S.A de C.V. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Contract Research Organization | Zapopan | Jalisco | 45010 | Mexico |
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| Label | URL |
|---|---|
| Mexican Registry of Clinical trials. The Federal Commission for the Protection against Sanitary Risk (COFEPRIS) | View source |
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Electronic Case Report Format (eCRF). The on line registry in a digital platform will help to verification process.
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The study raised 120 research subjects, only 116 were selected, 2 left the study before being evaluated for a total of 114. However, 7 subjects were eliminated by: closure of center 1, without monitoring 2, by loss of follow-up 2, non-compliance with inclusion criteria 1 and failure of scrutiny 1, leaving a total of 107 randomized research subjects
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence 1 (PRO-067) | study subjects will be allocated to receive PRO-067 QD for 30 days, after which they will be crossed over to the other medication (GAAP Ofteno®) for another 30 days. The Intraocular pressure-reducing effect of the medications will be assessed by the reduction in IOP after each medication compared to baseline. Washout period: 21 hours PRO-067: 1 drop QD during 30 days is a sterile ophthalmic solution formulated by Laboratorios Sophia S.A. de C.V. GAAP Ofteno®: 1 drop QD during 30 days Active comparator, reference medication. |
| FG001 | Sequence 2 (GAAP Ofteno®) | study subjects will be allocated to receive GAAP Ofteno® QD for 30 days, after which they will be crossed over to the other medication (PRO-067) for another 30 days. The Intraocular pressure-reducing effect of the medications will be assessed by the reduction in IOP after each medication compared to baseline. Washout period: 21 hours PRO-067: 1 drop QD during 30 days is a sterile ophthalmic solution formulated by Laboratorios Sophia S.A. de C.V. GAAP Ofteno®: 1 drop QD during 30 days Active comparator, reference medication. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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the estadistic analysis was performed by protocol for the primary variable and by intention to treat in tolerability and adverse events.
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| ID | Title | Description |
|---|---|---|
| BG000 | Sequence 1 (PRO-067) | 60 study subjects will be allocated to receive PRO-067 QD for 30 days, after which they will be crossed over to the other medication (GAAP Ofteno®) for another 30 days. The Intraocular pressure-reducing effect of the medications will be assessed by the reduction in IOP after each medication compared to baseline. Washout period: 21 hours PRO-067: 1 drop QD during 30 days is a sterile ophthalmic solution formulated by Laboratorios Sophia S.A. de C.V. GAAP Ofteno®: 1 drop QD during 30 days Active comparator, reference medication. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Target Intraocular Pressure (TIOP) | Target Intraocular Pressure (TIOP): Efficacy of experimental drug or active comparator to maintain the IOP in a range at which a patient is likely to remain stable or at which worsening of glaucoma will be slow enough that the risk of additional intervention is not justified.The upper limit of intraocular pressure is: TIOP + 2 mmHg. The measurement of the TIOP in each treatment period. | by Protocol | Posted | Mean | Standard Deviation | mmHg | the baseline visit (day 0), Cross Over Visit (day 30) and the final visit (day 60) for both sequences |
|
Adverse events were monitored during 75 days, from the baseline visit (day 1) to the safety call (day 75)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PRO-067 | PRO-067,QD for 60 days. Includes both periods of PRO-067 in sequence A and B. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjuntivitis | Eye disorders | Non-systematic Assessment |
The limitations of this study were its short duration (60 days) and the size of the groups that was reduced.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Oscar Olvera | Laboratorios Sophia | (33) 3001 4200 | 1074 | oscar.olvera@sophia.com.mx |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 1, 2016 | Feb 1, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D009798 | Ocular Hypertension |
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000077338 | Latanoprost |
| D011453 | Prostaglandins |
| ID | Term |
|---|---|
| D011461 | Prostaglandins F, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
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|
| GAAP Ofteno® | Drug | 1 drop QD during 30 days Active comparator, reference medication. |
|
|
| Percentage of Participants With Foreign Body Sensation | The foreign body sensation will be measured as present / absent according to each case. A Pearson´s chi-square test is performed in the crossover and final visit to compare the end of periods 1 and 2 between both study sequences. | basal visit (day 1), Crossover visit (day 30) and final visit (day 60) |
| Percentage of Participants With Tearing | The tearing will be measured as present / absent according to each case. A Pearson´s chi-square test is performed in the crossover and final visit to compare the end of periods 1 and 2 between both study sequences. | basal visit (day 1), Crossover visit (day 30) and final visit (day 60) |
| Percentage of Participants With Chemosis | The chemosis will be measured as present / absent according to each case. A Pearson´s chi-square test is performed in the crossover and final visit to compare the end of periods 1 and 2 between both study sequences. | basal visit (day 1), Crossover visit (day 30) and final visit (day 60) |
| Percentage of Participants With Hyperemia | the hyperemia of the study subjects was evaluated, during the baseline, crossover and final visit, the variable was described as a scale of: absent, very mild, mild, moderate and severe, according to the case, in both groups. A Pearson´s chi-square test is performed in the crossover and final visit to compare the end of periods 1 and 2 between both study sequences. | basal visit (day 1), Crossover visit (day 30) and final visit (day 60) |
| BG001 | Sequence 2 (GAAP Ofteno®) | 60 study subjects will be allocated to receive GAAP Ofteno® QD for 30 days, after which they will be crossed over to the other medication (PRO-067) for another 30 days. The Intraocular pressure-reducing effect of the medications will be assessed by the reduction in IOP after each medication compared to baseline. Washout period: 21 hours PRO-067: 1 drop QD during 30 days is a sterile ophthalmic solution formulated by Laboratorios Sophia S.A. de C.V. GAAP Ofteno®: 1 drop QD during 30 days Active comparator, reference medication. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| OG001 | Sequence B (GAAP Ofteno® - PRO-067) | Fist Period. GAAP Ofteno®: 1 drop QD (per day) during 30 days Active comparator, reference medication. Second Period. PRO-067: 1 drop QD during 30 days is a sterile ophthalmic solution formulated by Laboratorios Sophia S.A. de C.V. |
|
|
|
| Primary | Number of Adverse Events. | the two periods of PRO-067 of each sequence were grouped as well as those of GAAP to form two comparative groups of adverse events in each intervention. (PRO-067 vs. GAAP ofteno). The number of adverse events presented throughout the study was evaluated with each study drug to make the comparison between groups. | intention-to-treat (ITT), all those subjects who received at least one dose of the investigational drugs were considered for the statistical analysis, having a total of 107 cases by intention to treat. | Posted | Number | adverse events | it is evaluated from the baseline visit (day 1) to the security call (day 75) |
|
|
|
|
| Secondary | Percentage of Ocular Burning | the ocular burning of the study subjects was evaluated, during the baseline, crossover and final visit, the variable was described as present or absent, according to the case, in both groups. A Pearson´s chi-square test is performed in the crossover and final visit to compare the end of periods 1 and 2 between both study sequences. | analysis by protocol | Posted | Number | percentage of Ocular burning | at the basal visit (day 1) crossover visit (day 30) and final visit (day 60) |
|
|
|
|
| Secondary | Percentage of Participants With Foreign Body Sensation | The foreign body sensation will be measured as present / absent according to each case. A Pearson´s chi-square test is performed in the crossover and final visit to compare the end of periods 1 and 2 between both study sequences. | Analysis by protocol | Posted | Number | percentage of patients with Foreign body | basal visit (day 1), Crossover visit (day 30) and final visit (day 60) |
|
|
|
|
| Secondary | Percentage of Participants With Tearing | The tearing will be measured as present / absent according to each case. A Pearson´s chi-square test is performed in the crossover and final visit to compare the end of periods 1 and 2 between both study sequences. | Analysis by protocol | Posted | Number | percentage of patients with tearing | basal visit (day 1), Crossover visit (day 30) and final visit (day 60) |
|
|
|
|
| Secondary | Percentage of Participants With Chemosis | The chemosis will be measured as present / absent according to each case. A Pearson´s chi-square test is performed in the crossover and final visit to compare the end of periods 1 and 2 between both study sequences. | Analysis by protocol | Posted | Number | percentage of patients with chemosis | basal visit (day 1), Crossover visit (day 30) and final visit (day 60) |
|
|
|
|
| Secondary | Percentage of Participants With Hyperemia | the hyperemia of the study subjects was evaluated, during the baseline, crossover and final visit, the variable was described as a scale of: absent, very mild, mild, moderate and severe, according to the case, in both groups. A Pearson´s chi-square test is performed in the crossover and final visit to compare the end of periods 1 and 2 between both study sequences. | Analysis by protocol | Posted | Number | percentage of patients with hyperemia | basal visit (day 1), Crossover visit (day 30) and final visit (day 60) |
|
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| 0 |
| 51 |
| 0 |
| 51 |
| 24 |
| 51 |
| EG001 | GAAP Ofteno® | GAAP Ofteno®, QD for 60 days. Includes both periods of PRO-067 in sequence A and B. | 0 | 56 | 0 | 56 | 20 | 56 |
| itching | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| gastritis | Gastrointestinal disorders | Non-systematic Assessment |
|
| low back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| urinary tract infection | Renal and urinary disorders | Non-systematic Assessment |
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| vertigo | Ear and labyrinth disorders | Non-systematic Assessment |
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| rhinopharyngitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| constipation | Gastrointestinal disorders | Non-systematic Assessment |
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| headache | General disorders | Non-systematic Assessment |
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| pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| subconjunctival hemorrhage | Eye disorders | Non-systematic Assessment |
|
| Sleep disorder | General disorders | Non-systematic Assessment |
|
| arterial hypertension | Vascular disorders | Non-systematic Assessment |
|
| ankle bruise | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| dental process | Gastrointestinal disorders | Non-systematic Assessment |
|
| spasm orbicularis oculi | Eye disorders | Non-systematic Assessment |
|
| hypercholesterolemia | Endocrine disorders | Non-systematic Assessment |
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| venous insufficiency | Vascular disorders | Non-systematic Assessment |
|
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| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
| Final visit |
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| final visit (day 60) |
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| Final visit (day 60) |
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| final visit (day 60) |
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| Basal Visit Moderate |
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| Cross Over Visit Very Mild |
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| Cross Over Visit Mild |
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| Cross Over Visit Moderate |
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| Final visit Very Mild |
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| Final Visit Mild |
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| Final Visit Moderate |
|